达芬奇机器人手术系统与腹腔镜手术在子宫内膜癌全面分期手术中安全性和有效性的Meta分析

Safety and efficacy of Da Vinci surgical systemversus laparoscopy for surgical staging of endometrial cancer:a Meta-analysis

目的系统评价达芬奇机器人手术系统(DVSS)与腹腔镜手术在子宫内膜癌全面分期手术中的安全性与有效性。方法采用Cochrane系统评价法,应用计算机检索Cochrane library、PubMed、Embase、Web of Science(WOS)等英文数据库和中国知网(CNKI)、万方数据库、《中文科技期刊数据库》(CSTJ)等中文数据库;手工检索《国际肿瘤学杂志》《实用妇产科杂志》《中华妇产科杂志》《中国实用妇科与产科杂志》《现代妇产科进展》等中文期刊,检索年限为2007年1月1日至2017年8月31日,纳入DVSS与腹腔镜手术在子宫内膜癌全面分期手术的非随机对照试验(NRCT)。采用《纽卡斯尔-渥太华量表》(NOS)文献质量评价表,由2位经过该项目培训合格的研究者独立筛选文献、提取资料,并评价纳入研究的偏倚风险后,采用RevMan 5.3软件对DVSS和腹腔镜手术在子宫内膜癌全面分期手术中的安全性与有效性进行相关Meta分析。其中,安全性指标包括患者术中出血量、住院时间、中转开腹率、输血率、术中及术后并发症发生率,有效性指标包括手术时间、盆腔淋巴结切除数、腹主动脉旁淋巴结切除数。结果通过文献检查,并追踪检索已获取全文的相关参考文献,共计8篇符合本研究纳入标准,纳入患者为1 118例。在子宫内膜癌全面分期手术中,DVSS组患者为499例,腹腔镜手术组为619例。这8篇文献均为队列研究,其中前瞻性队列研究为3篇,回顾性队列研究为5篇。NOS量表评价文献质量均为高质量文献。本研究Meta分析结果显示,在子宫内膜癌全面分期手术中,(1)针对安全性方面的Meta分析结果显示,DVSS较腹腔镜手术具有患者术中出血量显著减少(SMD=-88.95,95%CI:-102.42^-75.47,P<0.001),住院时间显著缩短(SMD=-0.40,95%CI:-0.75^-0.06,P=0.02),中转开腹率显著降低(RR=0.37,95%CI:0.17~0.81,P=0.01),术中及术后并发症发生率显著降低(RR=0.67,95%CI:0.51~0.87,P=0.003)等优势,但2组患者的输血率比较,差异无统计学意义(RR=0.76,95%CI:0.39~1.50,P=0.43)。(2)针对有效性方面的Meta分析结果显示,2组患者的手术时间(SMD=3.21,95%CI:-21.51~27.93,P=0.80),盆腔淋巴结切除数(SMD=-0.23,95%CI:-3.06~2.60,P=0.87),及腹主动脉旁淋巴结切除数(SMD=0.77,95%CI:-1.69~3.23,P=0.54)比较,差异均无统计学意义(P>0.05)。结论在子宫内膜癌全面分期手术中,与腹腔镜手术相比,DVSS具有术中导致的患者出血量少、中转开腹率低、术中及术后并发症发生率低、住院时间短等优势。但是,DVSS因其费用昂贵而使临床应用受到一定限制。

Objective To evaluate the safety and efficacy between Da Vinci surgical system（DVSS）and laparoscopy for surgical staging of endometrial cancer.Methods All the non-randomized controlled trials（NRCT）about robotic surgery and laparoscopy for surgical staging of endometrial cancer were electronically collected by searching English databases,including Cochrane library,PubMed,Embase, Web of Science（WOS）,and Chinese databases,including China National Knowledge Infrastructure（CNKI）, Wanfang Database,China Science and Technology Journal Database（CSTJ）.Meanwhile,Journal of International Oncology,Journal of Practical Obstetrics and Gynecology,Chinese Journal of Obstetrics and Gynecology,Chinese Journal of Practical Gynecology and Obstetrics,Progress in Obstetrics and Gynecology were manually searched to collect NRCT about the same topic.Retrieval time ranged from January 1,2007 to August 31,2017.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies,then,Meta-analysis was performed by using RevMan 5.3 software.Heterogeneity inspection was done for each study,and different effect model,included the random effect model and fixed effect model was chose according to the results of the heterogeneity inspection.Meta-analysis was conducted to evaluate the efficacy and safety between robotic surgery and laparoscopy for surgical staging of endometrial cancer.The safety indexes included intraoperative blood loss,hospital stay,conversion to open surgery,blood transfusion rate,intraoperative and postoperative complications.The efficacy indexes included operation duration,the number of pelvic lymph node dissection and para-aortic lymph node dissection.Results A total of eight English NRCTs involving 1 118 patients were included.Among them,499 patients received robotic surgery and 619 patients received laparoscopic surgery.All the 8 articles were cohort study,3 were prospective cohort study,while 5 were retrospective cohort study.After the quality assessment,all studies were high quality.Meta-analysis showed the following results.（1） In term of the safty,compared with laparoscopy surgery,robotic surgery had less intraoperative blood loss（SMD=-88.95,95%CI：-102.42--75.47,P〈0.001）,shorter hospital stay（SMD=-0.40,95%CI：-0.75--0.06,P=0.02）,lower rate of conversion to open surgery（RR=0.37,95%CI：0.17-0.81,P =0.01）,and lower rate of intraoperative or postoperative complications（RR=0.67,95%CI：0.51-0.87,P=0.003）.But there was no statistically significant difference in term of blood transfusion rate（RR=0.76,95%CI：0.39-1.50,P=0.43）.（2）In terms of efficacy,there were no statistically significant differences in aspects of operative duration（SMD=3.21,95%CI：-21.51-27.93,P=0.80）,the number of pelvic lymph node dissection（SMD=-0.23,95%CI：-3.06-2.60,P =0.87）and the number of para-aortic lymph node dissection（SMD=0.77,95%CI：-1.69-3.23,P=0.54）.Conclusions Compared the robotic surgery with laparoscopic surgery in surgical staging of endometrial cancer,robotic surgery has less intraoperative blood loss,lower rate of conversion to open surgery,lower rate of intraoperative or postoperative complications and shorter hospital stay.But the cost of robotic surgery is still expensive which restricts clinical application.